Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05811364

The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

Sponsor: W.L.Gore & Associates

View on ClinicalTrials.gov

Summary

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

244

Start Date

2023-10-17

Completion Date

2032-01-31

Last Updated

2026-05-13

Healthy Volunteers

Conditions

Aortoiliac Occlusive Disease Peripheral Arterial Disease

Interventions

DEVICE

Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.

DEVICE

Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent

Treatment of target lesions in the common and/or external iliac arteries by stenting with a commercially available bare metal stent that is approved for treatment of the disease.

Inclusion Criteria: * Age ≥ 18 years at time of informed consent signature * Informed Consent Form (ICF) is signed by the subject * Subject can comply with protocol requirements, including follow-up * Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5) * Patient has de novo or restenotic lesion(s) found in the common and/or external iliac artery(ies) * Patient has: Unilateral or bilateral single or multiple lesions (\>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length * Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm * Patient has a sufficient (\<50% stenotic) common femoral artery and at least one sufficient (\<50% stenotic) femoral artery (deep or superficial). * Patient has at least one sufficient (\<50% stenotic) infrapopliteal run-off vessel. Exclusion Criteria: * Life expectancy \<1 year * Patient is pregnant at time of informed consent. * Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin). * Patient has severe chronic renal insufficiency (serum creatinine level \> 2.5mg/dL) and not undergoing hemodialysis. * Patient has evidence of a systemic infection. * Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use. * Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure). * Patient has previous stenting in the iliac arteries. * Patient has previous surgical bypass in the target limb. * Patient is currently participating in another investigative clinical study unless received written approval by the sponsor. * Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery. * Patient has an abdominal aortic artery lesion or aneurysm. * Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament. * Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery). * Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral / tibial revascularization).

Locations (43)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

VA Long Beach Healthcare System

Long Beach, California, United States

Denver Health and Hospital Authority

Denver, Colorado, United States

North Suburban Medical Center

Denver, Colorado, United States

University of Florida - Gainesville

Gainesville, Florida, United States

Radiology and Imaging Specialists of Lakeland

Lakeland, Florida, United States

University of South Florida

Tampa, Florida, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center, Inc.

Boston, Massachusetts, United States

Corewell Health System

Grand Rapids, Michigan, United States

The Curators of the University of Missouri

Columbia, Missouri, United States

Research Foundation SUNY Buffalo

Amherst, New York, United States

Trinity Medical Center

Buffalo, New York, United States

VA Western New York Healthcare System

Buffalo, New York, United States

New York University School of Medicine

New York, New York, United States

Mt. Sinai Medical Center

New York, New York, United States

Atrium Health

Charlotte, North Carolina, United States

University Hospitals - Cleveland Medical Center

Ashland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Portland Health Care System VA

Portland, Oregon, United States

Providence Heart & Vascular Institute

Wilsonville, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Sentara Medical Group

Norfolk, Virginia, United States

Central Adelaide Local Health Network Incorporated

Adelaide, Australia

Royal Perth Hospital

Nedlands, Australia

Prince of Wales Hospital

Randwick, Australia

Universitats-Herzzentrum Freiburg Bad Krozingen GmbH

Bad Krozingen, Germany

St. Franziskus Hospital

Münster, Germany

Krankenhaus der Barmherzigen Brüder

Regensburg, Germany

Klinikum Stuttgart

Stuttgart, Germany

Ospedale Niguarda Ca'Granda

Milan, MI, Italy

Ospedale Santa Maria della Misericordia

Perugia, Italy

Azienda Complesso Ospedaliero San Filippo Neri

Roma, Italy

Ospedale San Giovanni Molinette

Turin, Italy

Rijnstate Hospital

Arnhem, Netherlands

Stichting Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

Auckland City Hospital

Auckland, New Zealand

East Kent Hospitals University NHS Foundation Trust

Canterbury, United Kingdom

Guy's and St Thomas', NHS Foundation Trust

London, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom